510(k) · Cleared
ClearedBlackstone Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 17, 2008 as substantially equivalent to K081684 (Blackstone Medical, Inc., 2008) and 2 other predicates after a 24-day review. Its family tree reaches back 6 generations to 1998. 209 later devices descend from it.
- Decided
- Oct 17, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K980447 (1998). 21 ancestors in all. 209 later devices descend from it, 9 citing it directly.
- Root · 6 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 5 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 4 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 3 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 2 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- This deviceK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- Descendant · cites it directly · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- Descendant · cites it directly · 117 of its ownK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- Descendant · cites it directly · 116 of its ownK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- Descendant · cites it directly · 92 of its ownK100623 Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · Recalled
- Descendant · cites it directly · 88 of its ownK093926 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010
Showing 5 of 209 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 209 · See all- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · cites it directly130descendants
- K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010 · cites it directly117descendants
- K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012 · cites it directly116descendants
- K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 2010 · cites it directly92descendants
- K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010 · cites it directly88descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −5 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −4 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −3 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −2 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −1 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| 0 (this device) | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| +1 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| +1 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| +1 | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
| +1 | K100623 | Aesculap Implant Systems S4 Spinal System | Aesculap Implant Systems | 2010 | 1 |
| +1 | K093926 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 10 | 0 |
| 2017 | 18 | 0 |
| 2018 | 11 | 0 |
| 2019 | 15 | 0 |
| 2020 | 15 | 0 |
| 2021 | 12 | 0 |
| 2022 | 14 | 0 |
| 2023 | 26 | 0 |
| 2024 | 22 | 0 |
| 2025 | 21 | 0 |
| 2026 | 17 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081684 | Blackstone Pedicle Screw SystemSummary page 2…70 - Pedicle Screw Spinal System Review Panel: Orthopedic Device Panel Predicate Devices: Blackstone Medical, Inc. Pedicle Screw System (K081684 SE 9/15/08) Synthes Pangea Spine System (K052123 SE 9/23/0… | 2008 |
| * | K052123 | Synthes Pangea SystemSummary page 2…Blackstone Medical, Inc. Pedicle Screw System (K081684 SE 9/15/08) Synthes Pangea Spine System (K052123 SE 9/23/05 & K052151 SE 12-7-05) Intended Use / Indications for Use The Blackstone Pedic… | 2005 |
| * | K052151 | Synthes Pangea Monoaxial SystemSummary page 2…SE 9/15/08) Synthes Pangea Spine System (K052123 SE 9/23/05 & K052151 SE 12-7-05) Intended Use / Indications for Use The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedi… | 2005 |
What descends from it? (209)
See all 2099 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092624 | Firebird Spinal Fixation System | 2009 | 130 |
| K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | 2010 | 117 |
| K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | 2012 | 116 |
| K100623 | Aesculap Implant Systems S4 Spinal System | 2010 | 92 |
| K093926 | Firebird Spinal Fixation System | 2010 | 88 |
| K130932 | Firebird Spinal Fixation System | 2013 | 81 |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | 2019 | 29 |
| K200596 | G21 Cement, VADER® Pedicle System | 2020 | 27 |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | 2020 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K092624 (Blackstone Medical, Inc., 2009) has gone furthest, with 130 descendants of its own.
- 6 other devices also cite its predicate K081684.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use: 1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and…
Read the full statement (122 words)
The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use:
1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2) spondylolisthesis,
3) trauma (i.e., fracture or dislocation),
4) spinal stenosis,
5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6) tumor,
7) pseudoarthrosis, and
8) failed previous fusion
The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082797: Blackstone Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082797
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026